Drug Approval Package
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ProStep
(Nicotine Transdermal System) Patches
Company: Elan Pharmaceutical Research Corp.
Application No.: 19-983/S-012
Approval Date: 12/23/1998
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Approval Letter(s) (PDF) (989 KB)
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Medical Review(s) (PDF) (2.4 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.2 MB)
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Administrative Document(s)
Part 1 (PDF) (3 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (3 MB) -
Correspondence (PDF) (1 MB)
Date created: September 10, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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